1. Field of the Invention
The present invention is generally related to medical devices, and is more specifically related to packages for medical devices.
2. Description of the Related Art
During surgical procedures, great care is taken to prevent contamination of the medical devices that are used during operations. An operating team typically includes at least one member whose primary function is to open packages containing medical devices and to present the medical devices to a sterile nurse or surgeon in a manner that maintains the medical devices in a sterile condition.
A number of factors must be considered when designing packages for medical devices. First, the package must properly surround and protect the medical device from damage. Second, the packaging materials must be chosen to accommodate the sterilization process that will be used for the medical device. In addition, the package must be easy to open to enable efficient access of the medical device during a surgical procedure.
Packages for medical devices are also subject to considerations such as the cost of the materials, the cost and complexity of tooling to make the package, ease of package assembly, and ease of manufacture and shipping both the empty package and after the components are assembled together. An increasingly competitive economic environment exacerbates these sometimes competing considerations so that safety and efficacy must be achieved while costs are minimized.
It is particularly challenging to package elongated, bulky and/or relatively heavy medical devices. One solution is disclosed in commonly assigned U.S. Pat. No. 5,375,717 to Roshdy, which discloses a foldable package made from a sheet of cut and folded paperboard material. The package is used to retain an endoscope introducer and an instrument that is used with the endoscope introducer. The foldable package has openings and flaps that retain both the proximal and distal ends of the introducer. A proximal flap overlies the introducer. The proximal flap is used to release the package and expose the introducer, permitting the endoscope introducer to be removed from the package in one smooth motion.
Other efforts have been directed to providing packages for medical devices that allow for efficient opening of the package and presentation of the medical devices to surgical personnel in a sterile condition. One type of package provides a color-marked envelope that indicates the area to be torn off to provide an access opening to the contents within the envelope without affecting the sterility of the contents. Another type of package provides a tear string that may be pulled to open the envelope so that the contents may be removed using forceps or similar tools.
Commonly assigned U.S. Pat. No. 8,292,076 to Dacey et al. discloses sealed pouches for medical devices. In one embodiment, a sealed pouch includes first and second foil sheets having opposing inner surfaces that are joined together by a seal for defining a sealed area of the pouch located inside the seal and an unsealed area of the pouch located outside the seal. The sealed pouch includes a textured opening flange located adjacent an edge of the pouch for peeling the first and second foil sheets away from one another for breaking the seal and opening the sealed pouch. The textured opening flange is located within the unsealed area of the pouch and includes at least one roughened surface formed on at least one of the first and second foil sheets. A leg of the seal passes through the textured opening flange. The roughened surface on the textured opening flange makes it easier to break the leg of the seal for pulling the foil sheets apart.
In spite of the above advances in medical device packaging, there remains a need for improved packages for medical devices that are easy to open and that ensure the maintenance of strong seals prior to opening for maintaining a sterile environment inside the packages. There also remains a need for packages that ensure that the medical devices are held securely in place to avoid damage to the devices and/or the sealed outer pouches. There also remains a need for packages for medical devices that minimize the level of stress exerted upon the sealed outer pouches during loading, sterilization, shipping, and handling. In addition, there remains a need for packages whereby the medical devices may be easily removed from the packages without requiring partial or full disassembly of the packages. There also remains a need for packages that provide a clear indication of the end of the package that is to be opened. In addition, there is a need for flat trays that minimize the side of outer pouches and that minimize pouch buckling. Moreover, there remains a need for packages for top heavy medical device that enable medical personnel to consistently perform sterile transfers while minimizing the chance of dropping the medical devices.